Gentalek 80 mg/2 ml solution for injection/infusion
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Gentalek is and what it is used for.
2. Before you use Gentalek.
3. How to use Gentelek.
4. Possible side effects.
5. Storage of Gentalek.
6. Further information.
1. WHAT GENTLEK IS AND WHAT IT IS USED FOR
Gentalek is an antibiotic of the aminoglycoside group. It is effective against some Gram-positive bacteria and particularly effective in infections caused by Gram-negative bacteria.
Gentalek is intended for the treatment of severe infections such as:
– Sepsis, including neonatal sepsis,
– severe, recurrent urinary tract infections,
– infections of the lower respiratory tract,
– infections of the skin and soft tissues,
– infections of the central nervous system, including meningitis (inflammation of the brain membranes) in combination with topical administration,
– bone and joint infections,
– endocarditis (inflammation of the inner layer of the heart),
– infections of burns, traumatic and surgical wounds,
– infections in the abdomen and their prevention, particularly after surgical procedures in the urinary and intestinal tract.
Gentamicin is also the drug of choice in the treatment of severe bacterial infections caused by unidentified agents, and in infections which occur simultaneously with diseases which severely diminish the immune system of the body, e.g. leukemia, diabetes, corticosteroid therapy. In such cases gentamicin is usually used in combination with beta-lactam antibiotics.
2. BEFORE YOU ARE GIVEN GENTALEK
You should not be given Gentalek if you
– are allergic (hypersensitive) to gentamicin or to any of the other ingredients of Gentalek (see section 6 – Further Information),
– are allergic to other aminoglycoside antibiotics,
– have neurological disorder called myasthenia gravis.
Your doctor will take special care when giving Gentalek
– if you suffer from impaired kidney function,
– if you have auditory disorders or tinnitus,
– if you have vestibular disorders or vertigo
– if you have Parkinson’s disease,
– if you suffer from calcium, potassium or magnesium deficiency,
– if you are dehydrated,
– if you are older than 65 years,
– if the medicinal product is intended, for the treatment of a neonate.
Tell your doctor if any of these conditions exist.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal remedies, strong vitamins and minerals. Furthermore, do not take any new medicine without consulting your doctor.
Gentalek may interact with other medicines and influence their effects and/or cause side effects. This applies particularly to the following medicines:
– diuretics (water pills – ethacrynic acid and furosemide),
– muscle relaxants,
– other antibiotics which may cause auditory and vestibular disorders or renal impairment, especially streptomycin, neomycin, kanamycin, tobramycin, cephaloridine, paromomycin, viomycin, polymyxin B and colistin, amikacin, vancomycin, clindamycin, piperacillin,
– amphotericin B (for treating fungal infections),
– cyclosporin, tacrolimus (post-organ transplant medicine),
– methoxyflurane (anaesthetic),
– foscarnet, cidofovir (for treating viral infections),
– intravenous radioactive agents,
– cisplatin (for treating some forms of cancer),
– succinylcholine, tubocurarine (neuromuscular blocking agents).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Gentalek must not be used during pregnancy, except in urgent cases. Gentamicin should be used during pregnancy only in life-threatening situations when no other suitable antibiotic is available.
Because of the potential for adverse effects in the breast-fed infant, breast-feeding is not recommended.
Driving and using machines
There is no known effect of Gentalek on the ability to drive or use machines.
In some individuals, large doses of Gentalek may cause vestibular disorders accompanied by nausea and vertigo. The condition may worsen after the discontinuation of treatment.
Ask your doctor for advice if such disorders occur.
Important information about some of the ingredients of Gentalek
The medicine contains preservatives methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). They may cause allergic reactions (possibly delayed) and exceptionally, bronchospasm (difficulty breathing with wheezing or coughing). The medicine contains stabilizer sodium metabisulfite (E223): It may rarely cause severe allergic reactions and bronchospasm.
The medicine contains sodium: it contains less than 1 mmol (23 mg) of sodium per dose, which essentially means it is “sodium-free”.
3. HOW TO USE GENTALEK
The medicine will be given to you by a doctor or nurse, as it is injected in the muscle (intramuscular administration) or the vein (intravenous administration). Gentalek may also be administered in the form of intravenous infusion. The dose, route of administration and intervals between doses will be determined by the doctor. The medicine will be administered one to three times a day.
Usual dosage (normal kidney function)
Adults and children above 12 years of age: The usual daily dose of gentamicin in patients with moderate infections is 3 mg/kg body weight, divided into 1 to 3 doses. It is administered intramuscularly or intravenously. The usual dose in patients above 60 kg with normal renal function is 80 mg every 8 hours. In severe infections the dose is increased to 5 mg/kg daily.
Infants and children from 1 to 12 years of age: 4.5 mg/kg/day intramuscularly or intravenously, divided into 1 to 3 doses.
Newborn infants older than one week and infants up to one year of age: 6 mg/kg/day divided into 2 doses (administered every 12 hours).
Newborn infants in the first week of life: 5 mg/kg/day intramuscularly or intravenously, divided into 2 doses (administered every 12 hours).
Newborn infants are given Gentalek only in urgent cases. The treatment should be as short as possible. The doctor will determine the treatment.
Dosage in kidney Impairment
An altered dosage schedule of gentamicin is required in the presence of renal failure. The initial dose is the same as in patients with formal renal function; however, during the continuation of the treatment the interval between individual doses should be prolonged. Your doctor will adjust the dose of medicine accordingly.
Dosage in patients above 65 years of age
If you are above 65 years of age, the doctor will adjust the dosage according to your renal function.
Since equal doses of gentamicin may produce different concentration in different patients, serum gentamicin concentrations should be determined and the doses should be adjusted accordingly. The doctor or nurse will take a blood sample to determine the serum concentration of the medicinal product.
The maximum daily dose of gentamicin is 7.5 mg/kg divided into three doses.
If you are given more Gentalek than you should (overdose)
As Gentalek will be administered by a doctor or nurse, overdose is highly unlikely. Immediately inform your doctor if you notice signs of overdose (adverse effect on the vestibular (balance) and auditory (hearing) system, kidney impairment – severely decreased urine output, muscle weakness or difficulty breathing). Gentamicin is removed from the blood using haemodialysis. Exchange transfusion is suitable in newborn infants.
Removal of gentamicin is particularly important in patients with impaired kidney function.
If you do not receive Gentalek at the scheduled time
It is highly unlikely that you will not receive the medicinal product at the correct time prescribed by the doctor. Inform the doctor or nurse if you believe a dose has been missed.
Ask your doctor if you have any further questions.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gentalek can cause side effects, although not everybody gets them. The following side effects have been reported.
Uncommon (may occur in fewer than 1 in 100 patients): auditory disorder, vestibular disorder, sensation of pressure or ringing in the ears, vertigo, involuntary eye movement (nystagmus), nausea, vomiting, increased blood urea and creatinine levels.
Gentalek may impair auditory function, particularly with the concurrent presence of renal impairment. Inform your doctor if you notice newly occurring changes, e.g. vestibular (balance) disorders, vertigo, auditory (hearing) disorders, nausea or vomiting, sensation of pressure or ringing in the ears. Gentalek may also cause kidney dysfunction. Inform your doctor if you notice a significant decrease in the amount of urine you excrete.
Rare (may occur in fewer than 1 in 1000 patients): muscle pain, reduced blood levels of calcium, potassium and magnesium, neuromuscular transmission blockade, rash, itching (pruritus).
Very rare (may occur in fewer than 1 in 10,000 patients): palpitations (feeling of strong heart beats), headache, tiredness, paresthesia (sensations of tickling, itching or tingling without an apparent cause), visual disturbances, elevated body temperature, anaphylactic reaction (manifested as respiratory distress and swelling), anaemia, changes in blood cell levels. Elevated serum bilirubin levels and increased activity of liver enzymes (transaminases) may also be present.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or other medical staff.
5. STORAGE OF GENTALEK
Keep out of the reach and sight of children!
Do not use Gentalek after the expiry date imprinted on the package. The expiration refers to the last day of the imprinted month.
Store below 25 °C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
6. FURTHER INFORMATION
What Gentalek contains
– The active substance is gentamicin in the form of gentamicin sulfate. 1 ml of solution for injection/infusion contains 10, 20, 40 or 60 mg of gentamicin in the form of gentamicin sulfate.
– Excipients: disodium edetate, methyl parahydroxybenzoate (E21 8), sodium metabisuffite (E223), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide (for pH adjustment), sulphuric add (for pH adjustment), water for injections.
What Gentalek looks like and contents of the pack
Gentalek is a solution for injection/infusion. The solution is colourless to almost colourless, clear and free of visible particles.
The medicine is available in different pack sizes containing 10 ampoules of 80mg/2ml.
Availability of Gentalek
The medicine is available only with a prescription and is intended for hospital use only.
Lek PharmaceutIcals d.d., Verovskova 57, 1526 Ljubljana,
Marketing authorisation holder
Novartis Nigeria Limited
Mansard Place, 4th Floor, Bishop Aboyade Cole Street
Victoria Island, Lagos, Nigeria
This leaflet was last approved in November, 2016